Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement

Wanda Cui; Rodney P Rocconi; Ramya Thota; Richard A Anderson; Suanna S Bruinooge; Ioanna A Comstock; Neelima Denduluri; Audrey Gassman; Julie Gralow; Karla J Hutt; Laleh Amiri-Kordestani; Matteo Lambertini; John Leighton; Karen H Lu; Sogol Mostoufi-Moab; Teri Pollastro; Shan Pradhan; Haleh Saber; Caroline Schenkel; Daniel Spratt; Suparna Wedam; Kelly-Anne Phillips

doi:10.1016/S1470-2045(23)00390-X

Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement

Lancet Oncol. 2023 Oct;24(10):e415-e423. doi: 10.1016/S1470-2045(23)00390-X.

Authors

Wanda Cui¹, Rodney P Rocconi², Ramya Thota³, Richard A Anderson⁴, Suanna S Bruinooge⁵, Ioanna A Comstock⁶, Neelima Denduluri⁷, Audrey Gassman⁶, Julie Gralow⁵, Karla J Hutt⁸, Laleh Amiri-Kordestani⁹, Matteo Lambertini¹⁰, John Leighton¹¹, Karen H Lu¹², Sogol Mostoufi-Moab¹³, Teri Pollastro¹⁴, Shan Pradhan¹⁵, Haleh Saber¹¹, Caroline Schenkel¹⁶, Daniel Spratt¹⁷, Suparna Wedam⁹, Kelly-Anne Phillips¹⁸

Affiliations

¹ Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia.
² The University of Mississippi Medical Center, Cancer Center & Research Institute, Jackson, MS, USA.
³ Intermountain Health, Murray, UT, USA.
⁴ Medical Research Council Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
⁵ American Society of Clinical Oncology, Alexandria, VA, USA.
⁶ Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Division of Urology, Obstetrics, and Gynecology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
⁷ AstraZeneca, Gaithersburg, MD, USA.
⁸ Development and Stem Cell Program and Department of Anatomy and Developmental Biology, Biomedicine Discovery Institute, Monash University, Clayton, VIC, Australia.
⁹ Division of Oncology 1, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
¹⁰ Department of Internal Medicine and Medical Specialties, School of Medicine, University of Genova, Genoa, Italy; Department of Medical Oncology, UO Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
¹¹ Division of Hematology Oncology Toxicity, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
¹² Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹³ Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
¹⁴ Metastatic Breast Cancer Alliance, New York, NY, USA.
¹⁵ Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
¹⁶ American Society of Clinical Oncology, Alexandria, VA, USA. Electronic address: caroline.schenkel@asco.org.
¹⁷ Moffitt Cancer Center and Research Institute, Cleveland, OH, USA.
¹⁸ Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.

PMID: 37797647
DOI: 10.1016/S1470-2045(23)00390-X

Abstract

Anticancer agents can impair ovarian function, resulting in premature menopause and associated long-term health effects. Ovarian toxicity is not usually adequately assessed in trials of anticancer agents, leaving an important information gap for patients facing therapy choices. This American Society of Clinical Oncology (ASCO) statement provides information about the incorporation of ovarian toxicity measures in trial design. ASCO recommends: (1) measurement of ovarian toxicity in relevant clinical trials of anticancer agents that enrol post-pubertal, pre-menopausal patients; (2) collection of ovarian function measures at baseline and at 12-24 months after anticancer agent cessation, as a minimum, and later in line with the trial schedule; and (3) assessment of both clinical measures and biomarkers of ovarian function. ASCO recognises that routine measurement of ovarian toxicity and function in cancer clinical trials will add additional complexity and burden to trial resources but asserts that this issue is of such importance to patients that it cannot continue to be overlooked.

Publication types

Review

MeSH terms

Antineoplastic Agents* / adverse effects
Female
Humans
Medical Oncology
Neoplasms* / therapy
Ovary
United States

Substances

Antineoplastic Agents